Center for Devices and Radiological Health

Results: 3105



#Item
501Medical device / Hypnosis / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Hypnotherapy / Title 21 CFR Part 11 / Medicine / Food and Drug Administration / Health

[Typeface and font – Text is 12 point (pt), Times New Roman font unless it is bolded

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Source URL: www.fda.gov.

Language: English
502Technology / Premarket approval / Medical device / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Priority right / Individual Taxpayer Identification Number / Filing / Food and Drug Administration / Medicine / Health

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance for Industry and Food and Drug Administration Staff Document issued on: December 31, 2012

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Source URL: www.fda.gov.

Language: English
503Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / New Drug Application / Debarment / Clinical research / Center for Devices and Radiological Health / Center for Biologics Evaluation and Research / Food and Drug Administration / Health / Medicine

[removed]Federal Register / Vol. 77, No[removed]Tuesday, December 11, [removed]Notices procedures that CDRH and CBER intend to follow when industry representatives or application sponsors request a

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Source URL: www.gpo.gov

Language: English - Date: 2012-12-11 00:51:00
504Medical equipment / Food and Drug Administration / Aerospace engineering / Nadcap / Audit / Quality management system / Medical device / Center for Devices and Radiological Health / Patient safety / Medicine / Health / Quality management

Program Overview & Value Proposition 1 © Performance Review Institute Content

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Source URL: www.p-r-i.org

Language: English - Date: 2014-08-11 10:53:36
505Pharmaceutical sciences / Form FDA 483 / Center for Biologics Evaluation and Research / Office of Regulatory Affairs / Center for Drug Evaluation and Research / Good manufacturing practice / Center for Devices and Radiological Health / Biologic / Center for Food Safety and Applied Nutrition / Food and Drug Administration / Medicine / Health

Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services

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Source URL: www.fda.gov.

Language: English
506

1 FOOD AND DRUG ADMINISTRATION + + + + + CENTER FOR DEVICES AND RADIOLOGICAL HEALTH + + + + + MEDICAL DEVICES ADVISORY COMMITTEE

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Source URL: www.fda.gov

Language: English - Date: 1999-12-27 06:05:15
    507Health / Quality management system / Medical device / Design controls / Office of Regulatory Affairs / Validation / Center for Devices and Radiological Health / Quality assurance / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Technology

    FOOD AND DRUG ADMINISTRATION GUIDE TO INSPECTIONS OF QUALITY SYSTEMS

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    Source URL: www.fda.gov.

    Language: English
    508Pharmaceutical industry / Pharmacology / Adverse event / Food and Drug Administration / Clinical research / Research / Pharmaceutical sciences

    FDA PERSPECTIVE ON OPPORTUNITIES FOR PAS IMPLEMENTATION Veronica Sansing, PhD, MS US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH)

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    Source URL: www.fda.gov

    Language: English
    509Pharmaceutical sciences / MedWatch / Medical device / Adverse event / Center for Devices and Radiological Health / Unique Device Identification / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

    Medical Device Reporting for User Facilities DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration

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    Source URL: www.fda.gov.

    Language: English
    510Technology / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medical device / Center for Devices and Radiological Health / Good manufacturing practice / Title 21 of the Code of Federal Regulations / Investigational Device Exemption / Title 21 CFR Part 11 / Food and Drug Administration / Medicine / Health

    The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

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    Source URL: www.fda.gov.

    Language: English
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